1. Oversight Models for Clinics Performing Outpatient Procedures
Presentation to the Association of Health Facilities Survey Agencies Annual Meeting – August 2017
Deirdre Astin, Deputy Director
Division of Hospitals and Diagnostic & Treatment Centers
New York State Department of Health

2. Background
New York State licenses outpatient clinics as Diagnostic and Treatment Centers (DTCs) under Article 28 of 10NYCRR
State licensed DTCs include federally designated clinics such as ASCs, ESRDs, FQHCs, RHCs, CORFs and OPRTs.
Federally designated DTCs must comply with both federal and State regulations.

3. Background
Currently all clinics performing surgical and invasive procedures require licensure and federal certification as an ASC as well as approval through a certificate of need (CON) review and must meet higher physical plant standards.
Article 28 requires that all ASCs in New York State be accredited-NYS performs surveys every 4.5 years
ASCs can be deemed-NYS will perform validation surveys as requested by CMS.

4. Background
There is a demand to perform more invasive diagnostic therapeutic and surgical procedures in a less restrictive, non-ASC licensed outpatient setting, which creates additional risks due to the increased levels of anesthesia and other factors. This demand is driven by:
New technologies and techniques that are less invasive, safer and easier to use;
Patient and/or physician preferences for alternatives to inpatient hospital care;
Desire to provide high quality care in the most cost-effective setting-insurance carriers paying for procedures to be done in less costly settings.

5. Approach
A workgroup was formed to develop New York State CON, licensure and surveillance models for the oversight of outpatient procedures to evaluate the inherent risks and appropriate settings. The workgroup took the following approach:
Assessed the nature of outpatient procedure inquiries to the NYSDOH;
Reviewed related CON applications;
Examined the literature;
Consulted with medical specialty societies and expert clinicians of various specialties.

6. Approach
Key factors were identified to stratify the various Article 28-licensed outpatient settings:
Patient selection criteria and co-morbidities/risk factors;
Ability to manage a patient experiencing an unintended adverse event and transport to a higher level of care;
Invasiveness and complexity of the procedure(s);
Equipment/energy to be utilized;
Level of sedation/anesthesia;
Room type and physical plant standards;
Quality assurance/risk mitigation practices.

7. Guiding Principles
The following principles guided the recommendations of the workgroup:
Patients should have vital signs within normal limits for the general population or those of the involved patient, be in good or fair condition with no evidence of specified absolute exclusion criteria.
Administration of sedation and anesthesia must be consistent with regulatory requirements and professional standards and performed in locations with the ability to provide appropriate sedation and anesthesia care.

8. Guiding Principles, continued
Procedures must be conducted consistent with regulatory requirements and professional standards assuring patient safety and comfort. Procedures must be performed in locations with the ability to provide appropriate care guided by factors including but not limited to procedural urgency, invasiveness and associated infection control requirements, and complexity of the procedure.

9. Guiding Principles, continued
In outpatient settings located on the campus of a general hospital, providers have greater capacity to rescue a patient encountering an unexpected event or complication and may perform more complex procedures than those located in an off-site location.
Facilities must comply with all components of the NYS Surgical and Invasive Procedure Protocol to ensure that the requirements for patient identification, site marking, pre-operative/pre-procedural verification, and “time out” whenever procedures are performed.

10. Recommendations
Outpatient clinics can currently be licensed in two service categories:
Medical Services (Primary Care and/or Other Medical Specialties),
Ambulatory Surgery
A third category would be added-Outpatient Procedures.

11. Recommendations
Medical Services (Primary Care and/or Other Medical Specialties): Providers will be limited to performing non-invasive procedures involving local or peripheral regional anesthesia and/or minimal sedation. Outpatient Procedures: Providers may perform non-invasive and/or minimally invasive procedures and/or administer up to moderate sedation and epidural anesthesia. Ambulatory Surgery: Providers may perform non-invasive, minimally invasive and/or invasive procedures and/or administer deep sedation, spinal anesthesia or general anesthesia.

12. Considerations
The workgroup identified procedural criteria for determining the appropriate outpatient setting and physical plant requirements:
Urgency (routine, urgent, emergency)
Invasiveness (non-invasive, minimally invasive, invasive)
Sedation Level (minimal, moderate, deep)
Anesthesia Type (local/peripheral, epidural, spinal, general)
Sterile field/Environment (aseptic vs. sterile)

13. Considerations
Also identified were architectural and engineering criteria:
Pre-procedure area (dedicated staffed and monitored space)
Room types (exam, treatment, procedure, OR)
Imaging room types
class1-diagnostic, non-invasive
class 2-procedural, minimally invasive
class 3- surgical, invasive
Energy assisted devices (externally applied, internally applied)
Post procedure area (dedicated, staffed and monitored)

14. Considerations Clinical Surveillance Criteria were also identified:
1) Patient related factors
Absolute exclusion criteria-ASA* class 4 or greater, BMI >= 45, MI within past 6 months, unstable angina, stroke within past 8 weeks, CHF admission within past 4 weeks, COPD admission within past 4 weeks.
Relative exclusion criteria-if anesthesia personnel are unavailable include: difficult airway, hx of major adverse anesthesia reaction, AICD, sleep apnea, on 02 or anticoagulant, pulmonary hypertension or malignant hyperthermia.
* American Society of Anesthesiologists

15. Considerations Clinical Surveillance Criteria, continued.
2) Procedural Complexity
Procedure length;
Potential blood loss;
Risk of needing to convert to an open procedure;
Risk of adverse event not manageable in the setting and requiring emergent transfer to higher level of care.

16. Considerations Clinical Surveillance Criteria, continued.
3) Recovery Factors
Time to meet post-procedure discharge criteria (<1hr, <2hr, <4hr, <24 hr),
Need for recovery time/post procedure monitoring (none, <4hr, <6hr, <24 hr)

17. Outpatient Procedures
Process
Table 1: Criteria for Determining Appropriate Outpatient Setting and Associated Service Designation
Certified Service
Medical Services
Outpatient Procedures
Ambulatory Surgery
Inpatient Surgery
Off-Site
On-Campus
1. Criteria Applicable to Clinical Surveillance & Architecture and Engineering Review a.
Urgency
Routine
Yes
Urgent No
Emergency b.
Procedural Invasiveness
Non-invasive
(Diagnostic & Therapeutic)
Minimally Invasive (Procedural)
Invasive (Surgical) c.
Sterile Field/ Environment
Aseptic field
Sterile environment d.
Sedation Levels
Minimal (Min)
Moderate (Mod)
Deep e.
Anesthesia Types
Local; peripheral regional (PR)
Epidural (Epi)
Central Regional Anes. (CR)
Spinal anesthesia (SA)
General anesthesia (GA)
2. Architectural and Engineering Criteria
Pre-Procedure Area
Dedicated preparation & monitoring space and staffing
Room Types
Exam
Treatment
Procedure
Operating Room
Imaging Room (Classifications)
Class 1: Non-Invasive (Diagnostic)
Class 2: Minimally Invasive (Procedural)
Class 3: Invasive (Surgical)
Energy Assisted Devices
Externally applied
Internally applied
Post-procedure Area
Dedicated post-procedure monitoring space and staffing
3. Clinical Surveillance Criteria
Patient Related Factors
Absolute Exclusion Criteria Apply
Relative Exclusion Criteria Apply
Procedural Complexity
Procedure length
< 1hr
< 2hr
< 3hr
< 6hr
No limit
Potential blood loss
< 100ml
< 300ml
< 500ml
Risk of needing to emergently convert to an open procedure
Risk of unexpected adverse event that the setting is not equipped to handle & requiring emergent transfer to higher level of care.
None
Minimal
Low
Low-Mod NA
Recovery Factors
Time to meet post-procedure discharge criteria
< 4hr
< 24h
Need for recovery time/post-procedure monitoring
Tables developed to indicate the application of the various considerations to the different service categories and room types, to allow providers to determine the appropriate level of care .

18. Determination of Setting
PROCESS-STEP ONE
Determination of Setting
Invasiveness/Sterility
Non-Invasive
Sterile Field?
Sterile Environment?
Minimally Invasive
Invasive
Medical Services
Outpatient Procedures
Ambulatory Surgery
Ambulatory Surgery
Anesthesia/Sedation
Local, Peripheral, Regional
Moderate, Epidural
Outpatient Procedures
Ambulatory Surgery
Deep, General, Spinal

19. PROCESS-STEP TWO Determination of Room Invasiveness/Sterility
Non-Invasive
Sterile Field?
Sterile Environment?
Minimally Invasive
Invasive
Exam, Treatment, Procedure Room
Operating Room
Anesthesia/Sedation
Local, Peripheral, Regional
Moderate, Epidural
Procedure Room
Operating Room
Deep, General, Spinal

20. Additional Requirements
Additional requirements and recommendations:
History and physical, patient assessment
Admitting privileges and/or transfer agreements;
Staff trained in ACLS and/or PALS;
Equipment monitoring, e.g. capnography
Recovery areas to observe and monitor patient
Evaluation for anesthesia recovery
Intubation, airway rescue equipment, reversal agents
Patient discharge education
Staffing guidelines

21. Open Issues
Should accreditation be required for facilities licensed in the Outpatient Procedures service category (ASCs in New York State must be accredited either by a deemed or non-deemed agency)
What is the appropriate survey interval? Clinics licensed in the Primary Care or Medical Specialties service categories are surveyed every 5 years, non-deemed ASCs are surveyed more frequently; a sample of deemed ASCs receive validation surveys as directed by CMS.

22. Next Steps Outreach to provider community for input
Updates/changes to existing regulations
Determine appropriate survey interval
Develop application procedures for clinics seeking to add the new Outpatient Procedures service category to their license
Develop guidance to providers to help them select the service category and setting
Training for licensure unit staff performing reviews of licensure and certificate of need applications
Training for survey staff

23. Acknowledgements Ruth Leslie, Director, DHDTC Lisa McMurdo, RN, MPH
Nancey Agard, RN, MS
Linda Tripoli, RN

24. Questions?